Implant With Structural Members Arranged Around A Ring

ABSTRACT

An implant for use in a spine includes a body and a plurality of structural members. The superior and inferior surfaces each include a ring and structural members arranged in a web-like pattern around the ring. Bone contacting members are arranged radially away from the ring and support members are arranged in a circumferential direction around the ring.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of Bishop et al., U.S. PatentApplication Publ. No. 2018/0256351, published Sep. 13, 2018, andentitled “Implant with Structural Members Arranged Around a Ring,” theentire disclosure of which is hereby incorporated by reference.

BACKGROUND

The embodiments are generally directed to implants for supporting bonegrowth in a patient.

A variety of different implants are used in the body. Implants used inthe body to stabilize an area and promote bone ingrowth provide bothstability (i.e. minimal deformation under pressure over time) and spacefor bone ingrowth.

Spinal fusion, also known as spondylodesis or spondylosyndesis, is asurgical treatment method used for the treatment of various morbiditiessuch as degenerative disc disease, spondylolisthesis (slippage of avertebra), spinal stenosis, scoliosis, fracture, infection or tumor. Theaim of the spinal fusion procedure is to reduce instability and thuspain.

In preparation for the spinal fusion, most of the intervertebral disc isremoved. An implant, the spinal fusion cage, may be placed between thevertebra to maintain spine alignment and disc height. The fusion, i.e.bone bridge, occurs between the endplates of the vertebrae.

SUMMARY

In one aspect, an implant includes a body including a ring with anopening. The body defines a transverse plane dividing the implant into asuperior half and an inferior half. The ring defines a radial directionand a circumferential direction. The implant includes a bone contactingmember attached to the ring, where the bone contacting member extendsradially from the ring. The implant also includes a support memberattached to the bone contacting member at an attachment region, wherethe support member extends in the circumferential direction.

In another aspect, an implant includes a body. The body defines atransverse plane dividing the implant into a superior half and aninferior half. The implant includes a first bone contacting memberattached to the body and disposed within the superior half of theimplant. The implant also includes a first support member attached tothe first bone contacting member, the first support member beingdisposed within the superior half of the implant. The implant alsoincludes a second bone contacting member attached to the body anddisposed within the inferior half of the implant. The implant alsoincludes a second support member attached to the second bone contactingmember, the second support member being disposed within the inferiorhalf of the implant. An end of the first support member is attached toan end of the second support member.

In another aspect, an implant includes a body and a plurality of bonecontacting members extending from a central region of the body to aperiphery of the body. Each of the bone contacting members in theplurality of bone contacting members extend radially away from thecentral region of the body.

Other systems, methods, features and advantages of the embodiments willbe, or will become, apparent to one of ordinary skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features andadvantages be included within this description and this summary, bewithin the scope of the embodiments, and be protected by the followingclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, with emphasis instead being placed uponillustrating the principles of the embodiments. Moreover, in thefigures, like reference numerals designate corresponding partsthroughout the different views.

FIG. 1 is a schematic isometric superior view of an embodiment of animplant;

FIG. 2 is a schematic isometric inferior view of the implant of FIG. 1;

FIG. 3 is a schematic isometric view of a body of the implant of FIG. 1shown in isolation;

FIG. 4 is a schematic side view of the implant of FIG. 1;

FIG. 5 is a schematic isometric view of the implant of FIG. 1, includingan enlarged cut-away view of a structural member;

FIG. 6 is a schematic isometric view of a plurality of support membersarranged within the body of the implant of FIG. 1;

FIG. 7 is a schematic lateral side view of the implant of FIG. 1;

FIG. 8 is a schematic lateral side view of the implant of FIG. 1, inwhich the body has been removed for purposes of clarity;

FIG. 9 is a schematic isometric view of the implant of FIG. 1, in whichmember curves of several structural members are illustrated;

FIG. 10 is a schematic superior view of an embodiment of an implant;

FIG. 11 is a schematic depicting an implant attached to an implant tool,and where the implant is covered with a bone growth promoting material,according to an embodiment;

FIG. 12 is a schematic isometric view of an implant being positioned forinsertion between two vertebrae, according to an embodiment;

FIG. 13 is a schematic isometric view of the implant of FIG. 12 insertedbetween the two vertebrae;

FIG. 14 is a schematic side view of the implant of FIG. 13 including apartial cut-away view of a central cavity;

FIG. 15 is a schematic side view of the implant of FIG. 13 indicatingareas of new bone growth;

FIG. 16 is a schematic side view of the implant of FIG. 13 indicatingareas of new bone growth;

FIG. 17 is a schematic isometric view of the implant of FIG. 13including an enlarged view of the superior side of the implant;

FIG. 18 is a schematic isometric view of the implant of FIG. 13indicating areas of new bone growth on the superior side of the implant;

FIG. 19 is a schematic isometric view of the implant of FIG. 13indicating areas of new bone growth on the superior side of the implant;and

FIG. 20 is a schematic isometric view of new bone growth covering theimplant of FIG. 13.

DETAILED DESCRIPTION

The embodiments described herein are directed to an implant for use in aspine. The embodiments include implants with a body and one or morestructural members. In addition to the various provisions discussedbelow, any embodiments may make use of any of the body/supportstructures, frames, plates, coils or other structures disclosed inMorris et al., U.S. Pat. No. 9,918,849, issued on Mar. 20, 2018, andtitled “Coiled Implants and Systems and Methods of Use Thereof,” whichis hereby incorporated by reference in its entirety. For purposes ofconvenience, the Morris application will be referred to throughout theapplication as “The Coiled Implant Application”. Also, any embodimentsmay make use of any of the body/support structures, elements, frames,plates or other structures disclosed in McShane III et al., U.S.Publication Number 2019/0000642, published on Jan. 3, 2019, and titled“Implant with Arched Bone Contacting Elements,” which is herebyincorporated by reference in its entirety. Also, any embodiments maymake use of any of the body/support structures, elements, frames, platesor other structures disclosed in McShane III et al., U.S. PublicationNumber 2018/0110626, published on Apr. 26, 2018, and titled “Implantwith Protected Fusion Zones,” which is hereby incorporated by referencein its entirety and referred to as “The Protective Fusion Zonesapplication”.

FIGS. 1 and 2 illustrate isometric views of an embodiment of an implant100, which may be alternatively referred to as a device. Specifically,FIG. 1 is an isometric view of a top or superior side of implant 100,while FIG. 2 is an isometric view of a bottom or inferior side ofimplant 100. Implant 100 may also be referred to as a cage or fusiondevice. In some embodiments, implant 100 is configured to be implantedwithin a portion of the human body. In some embodiments, implant 100 maybe configured for implantation into the spine. In some embodiments,implant 100 may be a spinal fusion implant, or spinal fusion device,that is inserted between adjacent vertebrae to provide support and/orfacilitate fusion between the vertebrae.

In some embodiments, implant 100 may include a body 102. Body 102 maygenerally provide a frame or skeleton for implant 100. In someembodiments, implant 100 may also include a plurality of structuralmembers 104. Plurality of structural members 104 may be fixedly attachedto, and/or continuously formed (or “integrally formed”) with, body 102.As used herein, the term “fixedly attached” shall refer to twocomponents joined in a manner such that the components may not bereadily separated (for example, without destroying one or bothcomponents).

As used herein, each structural member comprises a distinctive member orelement that spans a portion of an implant. Structural members mayoverlap or intersect, similar to elements in a lattice or other 3D meshstructure. Some embodiments may use structural members in which thelength of the member is greater than its width and its thickness. Inembodiments where a structural member has an approximately circularcross-sectional shape, the structural member has a length greater thanits diameter. In the embodiments seen in FIGS. 1-2, each structuralmember is seen to have an approximately rounded or circularcross-sectional shape (i.e., the member has the geometry of a solidtube). However, in other embodiments, a structural member could have anyother cross-sectional shape, including, but not limited to, variouspolygonal cross-sectional shapes, as well as any other regular and/orirregular cross-sectional shapes. In some cases, for example, thecross-sectional size and/or shape of a structural member could varyalong its length (e.g., the diameter could change along its length).

For purposes of clarity, reference is made to various directionaladjectives throughout the detailed description and in the claims. Asused herein, the term “anterior” refers to a side or portion of animplant that is intended to be oriented towards the front of the humanbody when the implant has been placed in the body. Likewise, the term“posterior” refers to a side or portion of an implant that is intendedto be oriented towards the back of the human body followingimplantation. In addition, the term “superior” refers to a side orportion of an implant that is intended to be oriented towards a top(e.g., the head) of the body while “inferior” refers to a side orportion of an implant that is intended to be oriented towards a bottomof the body. Reference is also made herein to “lateral” sides orportions of an implant, which are sides, or portions, facing along alateral direction of the body (which correspond with the left or rightsides of a patient).

In FIGS. 1-2, implant 100 is understood to be configured with ananterior side 110 and a posterior side 112. Implant 100 may also includea first lateral side 114 and a second lateral side 116 that extendbetween the posterior side 112 and the anterior side 110 on opposingsides of implant 100. Furthermore, implant 100 may also include asuperior side 130 and an inferior side 140.

Reference is also made to directions or axes that are relative to theimplant itself, rather than to its intended orientation with regards tothe body. For example, the term “distal” refers to a part that islocated further from a center of an implant, while the term “proximal”refers to a part that is located closer to the center of the implant. Asused herein, the “center of the implant” could be the center of massand/or a central plane and/or another centrally located referencesurface.

An implant may also be associated with various axes. Referring to FIG.1, implant 100 may be associated with a longitudinal axis 120 thatextends along the longest dimension of implant 100 between first lateralside 114 and second lateral side 116. Additionally, implant 100 may beassociated with a posterior-anterior axis 122 (also referred to as a“widthwise axis”) that extends along the widthwise dimension of implant100, between posterior side 112 and anterior side 110. Moreover, implant100 may be associated with a vertical axis 124 that extends along thethickness dimension of implant 100 and which is generally perpendicularto both longitudinal axis 120 and posterior-anterior axis 122.

An implant may also be associated with various reference planes orsurfaces. As used herein, the term “median plane” refers to a verticalplane which passes from the anterior side to the posterior side of theimplant, dividing the implant into right and left halves, or lateralhalves. As used herein, the term “transverse plane” refers to ahorizontal plane located in the center of the implant that divides theimplant into superior and inferior halves. As used herein, the term“coronal plane” refers to a vertical plane located in the center of theimplant that divides the implant into anterior and posterior halves. Insome embodiments, the implant is symmetric about two planes, such as themedian and the transverse plane.

FIG. 3 illustrates a schematic isometric view of body 102 in isolation,with plurality of structural members 104 removed for purposes ofclarity. In some embodiments, a body could include distinct frameportions that are oriented in different directions. In the embodimentshown in FIG. 3, body 102 includes a peripheral frame portion 200, alsoreferred to as simply “peripheral portion 200”. In some embodiments,peripheral portion 200 has a longest dimension aligned with longitudinalaxis 120 and a widthwise dimension (e.g., the second longest dimension)aligned with posterior-anterior axis 122 of implant 100 (see FIGS. 1 and2). Peripheral frame portion 200 comprises a first lateral frame portion202, a second lateral frame portion 204 and a posterior frame portion206, which primarily lie in the transverse plane.

In some embodiments, one or more sides of an implant (including lateralsides and/or anterior/posterior sides) could include a verticallyoriented peripheral frame portion. In the embodiment of FIG. 3, body 102is seen to include a vertically oriented peripheral frame portion 208disposed at anterior side 110, which may also be referred to as an“anterior wall” of implant 100. In contrast, posterior side 112 lacksany frame portion or wall that extends vertically beyond the thicknessof peripheral portion 200 in the embodiments of FIGS. 3-4. The presenceof vertically oriented peripheral frame portion 208 may improve supportand strength against vertical loads applied along the anterior side ofthe spine.

Although the present embodiment uses a vertically oriented frame or wallon the anterior side of implant 100, in other embodiments, a verticallyoriented frame or wall could be located on the posterior side of implant100 and/or on a lateral side of implant 100. In still other embodiments,the implant may lack any vertical walls along its perimeter (i.e., alongthe posterior, anterior or lateral sides).

Embodiments may include one or more rings. In some embodiments, animplant could include two or more rings that are connected in a ringassembly. As seen in FIG. 3, body 102 includes a ring assembly 220. Ringassembly 220 is further comprised of a superior ring 222 and an inferiorring 224. Additionally, ring assembly 220 includes a first support 226and a second support 228 which extend through an interior region (andintersect the transverse plane) of implant 100 and join superior ring222 and inferior ring 224.

As seen in FIG. 3, ring assembly 220 may be arranged to form a hollowcylinder, which includes openings 230. This geometry may provide atubular space (central cavity 231) through which bone growth fromopposing vertebrae can extend through and fuse at the center of theimplant, thereby forming a strong cylindrical column of bone growth.Furthermore, the presence of openings 230 may allow new bone growth toextend from the column and fuse with bone growth occurring in adjacentregions of the interior of implant 100. Optionally, in otherembodiments, a ring assembly may comprise continuous cylindrical wallswith no openings.

In different embodiments, the location of a ring assembly could vary.For purposes of characterizing possible locations of a ring assembly, animplant may be divided into a first lateral side region, a secondlateral side region and a central region disposed between the firstlateral side region and the second lateral side region. In the exemplaryembodiment of FIG. 3, implant 100 includes a first lateral side region240, a central region 242 and a second lateral side region 244. In theexemplary embodiment, therefore, ring assembly 220 is disposed incentral region 242 and approximately equally spaced away from opposinglateral ends. Of course, in other embodiments, ring assembly 220 couldbe disposed in first lateral side region 240 or second lateral sideregion 244.

It may be appreciated that in other embodiments a ring assembly could bedisposed centrally with respect to a posterior/anterior direction.Though, in the present embodiment, ring assembly 220 extends the fulldistance between the posterior and anterior edges of implant 100.

In different embodiments, the shape of a ring could vary. In theexemplary embodiment, superior ring 222 and inferior ring 224 each havean oval-like shape. However, in other embodiments, a ring could have anyother shape including, but not limited to, a rounded shape, a circularshape, a triangular shape, a square shape, a polygonal shape, a regularshape, an irregular shape, etc.

A ring assembly, including a superior ring and an inferior ring, couldbe attached to other portions of the implant in various ways. In someembodiments, a ring assembly may be attached directly to a peripheralframe portion of a body. In other embodiments, a ring assembly could beattached to the body by way of one or more structural members. In theexemplary embodiment, ring assembly 220 is attached directly to bothperipheral frame portion 206 and vertically oriented peripheral frameportion 208, while also being attached to a plurality of structuralmembers (see FIGS. 1-2).

FIG. 4 is a side view of an embodiment of implant 100. In someembodiments, vertically oriented peripheral frame portion 208 couldinclude openings. In other embodiments, vertically oriented peripheralframe portion 208 may not include openings. In some embodiments,openings in a frame portion could provide an access point for insertingbone graft material or BGPM into an interior of an implant. The number,size and/or shape of openings in vertically oriented peripheral frameportion 208 could vary. In some cases, three or more openings could beused. In other cases, two openings could be used. In still other cases,a single opening could be used. Exemplary shapes for openings that couldbe used include, but are not limited to, rounded openings, rectangularopenings, polygonal openings, regular openings and/or irregularopenings. In the embodiment of FIGS. 3-4, vertically oriented peripheralframe portion 208 includes two large oval-shaped windows that mayfacilitate insertion of bone graft material (or BGMP) into an interiorof the implant. Specifically, vertically oriented peripheral frameportion 208 includes first window 210 and second window 212.

Some embodiments can include provisions that facilitate implantation,including insertion and/or fixation of the implant. Some embodiments caninclude a fastener receiving portion. For example, as best seen in FIGS.1-2, implant 100 includes a fastener receiving portion 160. Fastenerreceiving portion 160 includes a threaded opening 162 and a reinforcedcollar 164 to support threaded opening 162. In some embodiments,threaded opening 162 may be configured to receive a tool with acorresponding threaded tip to facilitate implantation of implant 100. Insome embodiments, threaded opening 162 may be used with a screw to helpattach implant 100 to a bone or another fixation device. In otherembodiments, any other features for receiving fasteners and/orimplantation tools could be incorporated into implant 100.

In some embodiments, an implant can be configured with one or moresymmetries. In some cases, an implant may have a mirrored symmetry aboutone or more reference planes.

Referring to FIGS. 1 and 2, implant 100 may include at least one mirrorsymmetry. For purposes of reference, implant 100 may be split into asuperior half and an inferior half. Here, the “superior half” of implant100 includes the portions of body 102 and plurality of structuralmembers 104 disposed above the transverse plane. Likewise, the “inferiorhalf” of implant 100 includes the portions of body 102 and plurality ofstructural members 104 disposed below the transverse.

With respect to the transverse plane (which coincides generally with theplane defined by first lateral frame portion 202, second lateral frameportion 204 and posterior frame portion 206), it may be seen that thesuperior half of implant 100 mirrors the inferior half of implant 100,at least approximately. This includes not only the geometry of the bodybut also the shape, size and orientations of each structural member.

Moreover, with respect to the median plane (which approximately dividesimplant 100 into two lateral halves), it may be seen that two lateralhalves mirror one another approximately. This includes not only thegeometry of the body but also the shape, size and orientations of eachstructural member.

An implant may include two or more kinds of structural members (orstructural elements). In some embodiments, an implant can include one ormore bone contacting structural members, or simply “bone contactingmembers”. Bone contacting members may generally be fully exposed on theouter surfaces of an implant, including along the superior and inferiorsides of the implant. Thus, bone contacting members may be alternativelyreferred to as “outer members”.

In some embodiments, an implant can include one or more structuralmembers that provide support to one or more bone contacting members.Such supporting structural members may be referred to as “supportmembers”. In some embodiments, at least some portions of each supportmember may be hidden or covered by a bone contacting member or anotherelement of the implant. Thus, support members may also be characterizedas “inner members” as they are generally disposed inwardly of the bonecontacting members.

FIG. 5 illustrates a schematic isometric view of implant 100, accordingto an embodiment. As seen in FIG. 5, implant 100 may include a pluralityof bone contacting members 180 as well as a plurality of support members182. As best shown in FIGS. 1-2, plurality of structural members 104 arearranged in four distinct quadrants on implant 100: a first quadrantassociated with superior side 130 and first lateral side region 240; asecond quadrant associated with superior side 130 and a second lateralside region 244; a third quadrant associated with inferior side 140 andfirst lateral side region 240; and a fourth quadrant associated withinferior side 140 and second lateral side region 244.

The following discussion discusses exemplary structural members in some,but not all, of the quadrants of implant 100. However, it may beappreciated that similar properties and principles of the specificstructural members discussed here may apply to structural members in anyof the remaining quadrants.

In some embodiments, one or more structural members could be closedloops without ends. In other embodiments, at least some structuralmember comprises two ends. In some cases, structural members with twoends could include one or more ends that are attached to anotherstructural member. In other cases, structural members with two endscould be arranged so that both ends are attached to a portion of a bodyof an implant. In the exemplary embodiment depicted in FIG. 5, eachstructural member includes two ends, with each end being attached tosome portion of body 102, or attached to another structural member, ofimplant 100.

In some embodiments, an implant may include at least one bone contactingmember with one end attached to a frame portion and another end attachedto a central ring. For example, as seen in FIG. 5, a bone contactingmember 300 includes a first end 302 attached to superior ring 222 and asecond end 304 attached to first lateral frame 202.

In different embodiments, support members could be attached to differentportions of an implant. In some embodiments, one or more ends of asupport member could be attached to a peripheral frame portion of abody. In other embodiments, one or more ends could be attached toanother support member. In still other embodiments, one or more portionsof a support member could be attached to a bone contacting member. Inone embodiment, each support member may be attached to a peripheralframe portion of the body, at least one bone contacting member, and atleast one other support member.

In the exemplary embodiment of FIG. 5, each support member includes oneend that is attached to a peripheral frame portion. For example, supportmember 340 includes a first end 342 that is attached to posterior frameportion 206. Likewise, the remaining support members of plurality ofsupport members 182 each have an end attached to either peripheral frameportion 206 or vertically oriented peripheral frame portion 208.

Embodiments may include provisions to minimize the number of bars orother supports needed. Some embodiments may include provisions thateliminate the need for any internal supports extending betweenperipheral frame portion 200 (shown in FIG. 5) and ring assembly 220,thereby increasing the interior volume available to receive new bonegrowth. In some embodiments, support members from opposing superior andinferior sides of an implant may attach directly to one another, therebyeliminating the need for additional longitudinally running structures toreceive the support members.

FIG. 6 is a schematic isometric view of plurality of support members 182with body 102 shown in phantom for purposes of clarity. FIG. 7illustrates a schematic lateral end view of implant 100, while FIG. 8illustrates a similar view with body 102 removed for purposes ofillustration. As seen in FIGS. 6-8, each support member includes an endthat is joined to three other support members at an area adjacent thetransverse plane. As an example, first superior support member 402,second superior support member 404, first inferior support member 406and second inferior support member 408 are all joined at an attachmentregion 410 that is located approximately in the transverse plane ofimplant 100. Specifically, as best seen in FIG. 8, an end 403 of firstsuperior support member 402, an end 405 of second superior supportmember 404, an end 407 of first inferior support member 406 and an end409 of second inferior support member 408 are all joined together. Usingthis arrangement, the support members provide reinforcement and supportin both the posterior-anterior directions and vertical directions ofimplant 100 without requiring additional support elements (e.g.,longitudinally running beams, bars or plates) that would serve asattachment points for the support members in the center of the implant.

In some embodiments, bone contacting members may be disposed distal tosupport members, with bone contacting members generally disposed furtheroutwards along the superior and inferior sides of an implant. Thus, bonecontacting members may generally be disposed closer to the vertebral endplates following implantation into the spine. Moreover, at regions wherea bone contacting member is attached to a support member, the attachedportion of the bone contacting member may be disposed distal to theattached portion of the inner member. As one example, FIG. 5 illustratesa schematic isometric view of implant 100 including an enlargedcross-sectional view of an attachment region 189 between bone contactingmember 370 and support member 390. Here, bone contacting member 370 isseen to extend up and over support member 390. Moreover, bone contactingmember 370 is seen to be located distally to support member 390. Here,distally is intended to mean disposed further from the transverse planeof implant 100.

Embodiments can include provisions for protecting bone growth along andadjacent to bone contacting members of an implant. In some embodiments,a bone contacting member can be configured with a geometry that helps toprotect new bone growth in selected regions or “protected fusion zones”.In some embodiments, a bone contacting member can have a spiral, helicalor twisted geometry that provide a series of such protected fusion zonesfor enhanced bone growth.

Some bone contacting members may have a generalized helical geometry. Asused herein, a “generalized helical geometry” or “spiraling geometry”refers to a geometry where a part (portion, member, etc.) winds, turns,twists, rotates or is otherwise curved around a fixed path. In somecases, the fixed path could be straight. In other cases, the fixed pathcan be curved. In the present embodiments, for example, the fixed pathis generally a combination of straight segments and curved segments.

Curves having a generalized helical geometry (also referred to asgeneralized helical curves) may be characterized by “coils”, “turns” or“windings” about a fixed path. Exemplary parameters that maycharacterize the specific geometry of a generalized helical curve caninclude coil diameter (including both a major and minor diameter) andthe pitch (i.e., spacing between adjacent coils). In some cases, the“amplitude” of a coil or loop may also be used to describe the diameteror widthwise dimension of the coil or loop. Each of these parameterscould be constant or could vary over the length of a generalized helicalcurve.

Generalized helical curves need not be circular or even round. In someembodiments, for example, a generalized helical curve could havelinearly segmented shape (or locally polygonal shape) such that each“coil” or “turn” is comprised of straight line segments rather than arcsor other curved segments. Generalized helical curves may also includecombinations of curved and straight segments. Examples of generalizedhelical curves are shown and described in The Protected Fusion ZonesApplication.

For purposes of characterizing the geometry of one or more structuralmembers, each structural member can be understood to have a “centralmember curve”. The central member curve of each structural member may bedefined as a curve that extends along the length of the structuralmember such that each point along the curve is centrally positionedwithin the structural member.

In embodiments where a structural member winds or loops around a fixedpath with an amplitude or diameter that is much greater than thecross-sectional diameter of the structural member itself, the structuralmember may be wound into visible distinct coils. Such coils arediscussed in thorough detail in the Coiled Implant Application. In otherembodiments, however, a structural member could be wound around a fixedpath with an amplitude or diameter that is less than the cross-sectionaldiameter of the structural member itself. In such a case the resultinggeometry of a structural member may appear to be twisted, but thegeometry may lack the distinct coils seen in the Coiled ImplantApplication. However, it may be appreciated that while the outermostsurface of such a structural member may not exhibit distinct coils, thecentral member curve of the structural member does have such coils orturns and moreover has a clear generalized helical geometry.

FIG. 9 is a schematic isometric view of implant 100 where the structuralmembers have been removed for purposes of clarity. To depict thegeometry of the structural members, the central member curve of severalstructural members is shown. Specifically, central member curve 520 isshown, which corresponds to the geometry of bone contacting member 300.Additionally, central member curve 504 and central member curve 506 areshown, which correspond with the geometry of support members providingsupport to bone contacting member 300.

As previously discussed, bone contacting member 300 (FIG. 5) exhibits atwisted geometry indicative of a spiral or helix. However, since thewinding occurs with an amplitude much smaller than the thickness of bonecontacting member 300, the geometry of the part may be difficult todiscern. The generalized helical geometry of bone contacting member 300becomes much clearer when the geometry of its central member curve 520(which is clearly seen in FIG. 9) is considered as it winds around afixed path 540 (also shown in FIG. 9).

In different embodiments, the winding diameter of a helical structuralmember could vary. In the exemplary embodiment, a winding diameter 552of the coils or turns in central member curve 520 are smaller than thediameter of bone contacting member 300. In other embodiments, thecross-sectional diameter of a bone contacting member could be less thana corresponding winding diameter of the coils or turns of its centralmember curve. In such an embodiment, the bone contacting member would beconfigured in a series of distinct coils.

A bone contacting member may not have a generalized helical geometrythrough its entire length. Instead, its central member curve may beconfigured with a winding segment where the central member curvecompletes several full turns (three in FIG. 9) around a fixed path. Awayfrom the winding segment, its central member curve may not include anyturns, twists, etc.

Although the present embodiment includes at least one bone contactingmember with a winding segment that makes one or more full turns around afixed path, other embodiments could be configured with central membercurves that only make partial turns around a fixed path.

While the description here has focused on the geometry of a single bonecontacting member 300, it may be appreciated that some or all of theremaining bone contacting members in plurality of structural members 104may have a similar generalized helical geometry. It may be furtherappreciated that two different bone contacting members could haveslightly different geometries, with distinct bone contacting membercurves that include variations in the number of windings, shape of thewindings, etc.

In some embodiments, an implant can include bone contacting members thatare locally helical over small distances compared to the length, widthor height of the implant. For example, implant 100 may be characterizedas having bone contacting members that are locally helical or locallyspiraling, rather than globally helical. In particular, each bonecontacting member of implant 100 is bounded within a single quadrant ofimplant 100 and does not cross the transverse plane or the median planeof implant 100. Thus, a full turn of the bone contacting members isaccomplished over distances that are much smaller than half the length,width or height of the implant. This allows multiple windings withineach quadrant of the implant and also results in the pitch betweenwindings being smaller than the length, width or height of the implant.For example, in FIG. 9, central member curve 520 has a pitch 529 betweenadjacent windings or turns that is less than one third of the length ofbone contacting member 300. Pitch 529 is also less than one tenth of thelength of implant 100. This relatively small pitch size allows for agreater number of proximal surface regions along each bone contactingmember, thereby increasing the number of available protected fusionzones of the inferior and superior surfaces of implant 100.

In some embodiments, the helix-like geometry of bone contacting membersprovides distinct regions exposed on the superior and inferior sides ofan implant. For example, referring to FIG. 5, each bone contactingmember includes one or more distal regions 360 that may be seen as“peaks” in the bone contacting member along the superior side 130 ofimplant 100. In at least some embodiments, these distal regions 360 maybe flattened or “smoothed” to provide a flat or smooth distal-mostsurface on superior side 130 (and inferior side 140), therebyfacilitating contact with adjacent vertebrae. In other embodiments, adistal surface region may be curved. In some cases, the distal surfaceregion could have a curvature that matches the curvature of the adjacentsurface regions of the bone contacting member. In other cases, thedistal surface region could have a different curvature (e.g., moreconvex) than adjacent surface regions of the bone contacting member.

Bone contacting members may also include proximal regions 362 that areconfigured as “valleys” in the bone contacting member along the superiorside 130 of implant 100. Whereas the distal regions 360 may come intocontact with the vertebrae during and following implantation of implant100, proximal regions 362 may be recessed or spaced apart from directcontact with the vertebrae, at least before new bone growth hasdeveloped.

As a particular example, FIG. 5 includes an enlarged cross-sectionalview of a portion of a bone contacting member 370 and underlying supportmember 390. Specifically, an outwardly facing surface portion 372 ofbone contacting member 370 is visible. As used herein, the “outwardlyfacing surface portion” of a bone contacting member is the portion ofthe surface of the bone contacting member facing towards a vertebraduring implantation, or facing away from an interior of the implant.Outwardly facing surface portion 372 includes a first distal surfaceregion 380, a proximal surface region 382 and a second distal surfaceregion 384. As discussed in further detail below, this local geometryprovides a series of protected fusion zones adjacent each proximalsurface region, where new bone growth can be protected during early bonefusion.

While bone contacting members may have generalized helical geometries,the geometries of the support members may be selected to enhancestrength and support. In some embodiments, support members could have agenerally tube-like (solid) shape and may extend in simple curves fromone portion of a body to another. In some cases, the central membercurve of a support member may be smoothly curved without any localtwists, windings or coils.

Thus, it may be appreciated, that in some embodiments, support membersmay generally be shorter and their geometry may be more arch-like toimprove strength and provide increased support for the bone contactingmembers. In contrast, the bone contacting members may generally have alonger length and may be less arch-like in shape relative to the supportmembers, as the bone contacting members need to extend across as much ofthe superior/inferior sides of an implant as possible to provide contactwith the vertebrae.

While some embodiments include bone contacting members with generalizedhelical geometries and support members with arch-like geometries, inother embodiments any structural member could be configured with anytype of geometry. For example, in another embodiment, one or moresupport members could have a generalized helical geometry that createprotected fusion zones along the support members. In still anotherembodiment, one or more bone contacting members could have an arch-likegeometry.

In different embodiments, the attachment between a support member and abone contacting member could occur at various locations. In someembodiments, a support member could be attached near a distal surfaceregion along the outer surface of a bone contacting member. In otherembodiments, a support member could be attached near a proximal surfaceregion along the outer surface of a bone contacting member.

In some embodiments, each support member is configured to attach to acorresponding bone contacting member at a location adjacent (orunderlying) a proximal surface region of the bone contacting member. Forexample, as shown in FIG. 5, an attachment region 189 of support member390 is attached to bone contacting member 300 at a locationcorresponding to proximal surface region 382 of bone contacting member300. Likewise, every other support member of implant 100 attaches to oneor more bone contacting members only at locations corresponding toproximal surface regions.

This configuration provides for protected fusion zones that encompassthe space immediately adjacent the proximal regions. The protectedfusion zones are locations along the superior/inferior surfaces of animplant where new bone growth can be partially protected from forcesapplied to the bone contacting members by adjacent support members ordirectly from a vertebra.

By configuring one or more bone contacting members with at least onehelical portion, the bone contacting member may provide one or moreprotected fusion zones on the superior and inferior sides of an implant.These protected fusion zones encompass the space immediately adjacentthe proximal regions of the bone contacting members. The recessed spacesprovided by the proximal regions allow for pockets of new bone growthadjacent initial fusion that may occur at the distal regions. Moreover,because the support members are attached near the proximal surfaceregions, and not at the distal surface regions, forces applied to thebone contacting members by either the support members or by a vertebracan be directed away from the protected fusion zones, thereby minimizingthe disturbance of new bone growth.

FIG. 10 is a schematic top down view of an implant 600, according to anembodiment. Referring to FIG. 10, implant 600 includes body 601comprising peripheral frame portion 602, peripheral frame portion 604,peripheral frame portion 606 and peripheral frame portion 608.Additionally, body 601 comprises ring 609 defining a central opening650.

For purposes of reference, central opening 650 (and ring 609) define aradial direction 599 and a circumferential direction 598. Here, radialdirection 599 extends outwardly from a center of central opening 650,while circumferential direction 598 is an angular direction that isperpendicular with radial direction 599.

In different embodiments, the orientation of bone contacting membersand/or support members could vary. In some embodiments, bone contactingmembers may be oriented radially away from a center of an implant. Insome embodiments, support members may be oriented in a circumferential(or angular) direction that rotates about a center of an implant. Inother embodiments, however, bone contacting members could be oriented ina circumferential direction while support members could be oriented in aradial direction. In still other embodiments, one or more structuralelements could be oriented in directions orthogonal to the length and/orwidth of an implant, rather than in radial and/or circumferentialdirections.

Implant 600 also includes plurality of bone contacting members 630 andplurality of support members 632. As seen in FIG. 10, plurality of bonecontacting members 630, which includes first bone contacting member 611,second bone contacting member 612, third bone contacting member 613 andfourth bone contacting member 614 may each extend in radial direction599 (i.e., outwardly from central opening 650 and ring 609). Forexample, first bone contacting member 611 extends radially from ring 609to peripheral frame portion 602. Second bone contacting member 612 alsoextends radially from ring 609 to peripheral frame portion 602, thoughsecond bone contacting element 612 has a different angular (orcircumferential) position along circumferential direction 598. Also,third bone contacting member 613 extends radially from ring 609 toperipheral frame portion 604. Fourth bone contacting member 614 alsoextends radially from ring 609 to peripheral frame portion 604, thoughfourth bone contacting element 614 has a different angular (orcircumferential) position along circumferential direction 598.

As seen in FIG. 10, plurality of support members 632 is furthercomprised of first support member 621, second support member 622, thirdsupport member 623, fourth support member 624, fifth support member 625,sixth support member 626, seventh support member 627 and eighth supportmember 628. Each of these support members may be oriented approximatelyin the circumferential direction 598. For example, first support member621 extends from peripheral frame portion 606 to its attachment withsecond support member 622 along a path 640 that is approximatelyparallel with the circumferential direction 598. Likewise, secondsupport member 622 extends from its attachment to first support member621 to peripheral frame portion 608 along a path 642 that is alsoapproximately parallel with circumferential direction 598. Moreover, itis clear from FIG. 10 that first support member 621 is approximatelyperpendicular with (radially oriented) first bone contacting member 611and that second support member 622 is approximately perpendicular with(radially oriented) second bone contacting member 612. Similarly, eachremaining support member in plurality of support members 632 is orientedapproximately parallel with circumferential direction 598 and is alsoapproximately perpendicular to a bone contacting member to which itattaches.

The embodiment of FIG. 10 may be characterized as having structuralmembers arranged in a web-like or spider web-like pattern. Moreover, itmay be appreciated that while only one side of implant 600 is shown, anopposing side may likewise include a central ring and structural membersoriented in a similar web-like pattern.

This web-like pattern provides radially oriented structural members(bone contacting members) that may help improve strength in multipledirections simultaneously (i.e., the longitudinal and lateraldirections). This may also help direct new bone growth from the centerof the device (which includes a large central cavity for bone growth)towards the corners and periphery of the device. Moreover, thecircumferential orientation of some structural members (support members)in this web-like pattern also improves the strength of the device inmultiple directions simultaneously and in directions orthogonal to theradially oriented structural members.

The arrangement of structural members with the body may also be designedto achieve a desired total open volume. As used herein a total volume isthe combined volume of any openings between structural members, anyopenings in the body, or between structural members and the body. Thisopen configuration may facilitate bone growth in and through theimplant. A portion, or substantially all of, the open spaces isoptionally filled with a bone graft or bone growth promoting materialprior to or after insertion of the implant to facilitate bone growth.

The total volume of the open spaces (also referred to simply as the openspace volume) within any particular implant is dependent on the overalldimension of the implant as well as the size and dimension of individualcomponents within the implant including structural members, frameportions, etc. The open space volume may range from about 20% to 80% ofthe volume of the implant. In some embodiments, implant 100 may have anopen space volume that is between 25% and 80% of the implant's totalvolume. In still further embodiments, implant 100 may have an open spacevolume that is between 40% and 75% of the total implant volume.

FIGS. 11-13 illustrate various schematic views of a process ofimplanting an implant 600. Referring first to FIGS. 11-13, theimplantation process may begin with the application of a bone growthpromoting material, also referred to as a BGPM, to the implant. As usedherein, a “bone growth promoting material” is any material that helpsbone growth. Bone growth promoting materials may include provisions thatare freeze dried onto a surface or adhered to the metal through the useof linker molecules or a binder. Examples of bone growth promotingmaterials are any materials including bone morphogenetic proteins(BMPs), such as BMP-1, BMP-2, BMP-4, BMP-6, and BMP-7. These arehormones that convert stem cells into bone forming cells. Furtherexamples include recombinant human BMPs (rhBMPs), such as rhBMP-2,rhBMP-4, and rhBMP-7. Still further examples include platelet derivedgrowth factor (PDGF), fibroblast growth factor (FGF), collagen, BMPmimetic peptides, as well as RGD peptides. Generally, combinations ofthese chemicals may also be used. These chemicals can be applied using asponge, matrix or gel.

Some bone growth promoting materials may also be applied to animplantable prosthesis through the use of a plasma spray orelectrochemical techniques. Examples of these materials include, but arenot limited to, hydroxyapatite, beta tri-calcium phosphate, calciumsulfate, calcium carbonate, as well as other chemicals.

A bone growth promoting material can include, or may be used incombination with, a bone graft or a bone graft substitute. A variety ofmaterials may serve as bone grafts or bone graft substitutes, includingautografts (harvested from the iliac crest of the patient's body),allografts, demineralized bone matrix, and various synthetic materials.

Some embodiments may use autograft. Autograft provides the spinal fusionwith calcium collagen scaffolding for the new bone to grow on(osteoconduction). Additionally, autograft contains bone-growing cells,mesenchymal stem cells and osteoblast that regenerate bone. Lastly,autograft contains bone-growing proteins, including bone morphogenicproteins (BMPs), to foster new bone growth in the patient.

Bone graft substitutes may comprise synthetic materials includingcalcium phosphates or hydroxyapatites, stem cell containing productswhich combine stem cells with one of the other classes of bone graftsubstitutes, and growth factor containing matrices such as INFUSE®(rhBMP-2-containing bone graft) from Medtronic, Inc.

It should be understood that the provisions listed here are not meant tobe an exhaustive list of possible bone growth promoting materials, bonegrafts or bone graft substitutes.

In some embodiments, BGPM may be applied to one or more outer surfacesof an implant. In other embodiments, BGPM may be applied to internalvolumes within an implant. In still other embodiments, BGPM may beapplied to both external surfaces and internally within an implant. Asseen in FIGS. 11-13, a BGPM 700 has been placed inside an interior ofimplant 600 and also applied on superior and inferior surfaces ofimplant 600. Moreover, as shown in FIG. 11, BGPM 700 has been insertedthrough (and extends through) a first window 662 and a second window 664of implant 600.

FIGS. 12 and 13 show schematic views of the implant pre-implantation(FIG. 12) and post-implantation (FIG. 13). Once implanted, implant 600may be disposed between, and in direct contact with, adjacent vertebra.Specifically, a superior side 702 of implant 600 is disposed againstfirst vertebra 712. Likewise, an inferior side 704 of implant 600 isdisposed against second vertebra 714.

In different embodiments, implantation methods could vary. In someembodiments, implant 600 may be secured to an implantation tool 701(partially seen in FIGS. 11-12) that is used to drive implant 600 intothe spine. Implantation tool 701 could be any rod, ram, pole or otherdevice that can be hammered, rammed, or otherwise driven to positionimplant 600 between adjacent vertebrae. As previously mentioned, in somecases, an implantation tool could be attached to implant 600 at afastener receiving portion (i.e., a threaded opening for receiving athreaded shaft from a tool).

FIGS. 14-20 depict a schematic sequence of bone growth throughoutimplant 600, including through central cavity 671 (FIGS. 14-16), as wellas along the superior and inferior sides of implant 600 (FIGS. 17-20).

FIGS. 14-16 depict a partial cross-sectional view of implant 600 justafter implantation between vertebra 712 and vertebra 714. Here, BGPM 700fills an interior of implant 600 and also coats the superior andinferior surfaces in contact with the vertebrae.

Initial bone fusion and growth may occur where the vertebrae are incontact with BGPM 700. With time, new bone growth begins to extend alongthe inferior and superior surfaces of implant 600 as well as intocentral cavity 671, as seen in FIG. 15. For example, in FIG. 15, newbone growth region 720 extends from vertebra 712 into central cavity 671while new bone growth region 722 extends from vertebra 714 into centralcavity 671. New bone growth regions 726 may also extend into theinterior spaces of implant 600 that are adjacent to central cavity 671.

Eventually, as seen in FIG. 16, a solid column of new bone growth 724may form throughout central cavity 671. This new bone growth in centralcavity 671, along with new bone growth associated with other regions ofthe interior and exterior of implant 600, helps to fuse vertebra 712 andvertebra 714.

FIGS. 17-20 depict a schematic sequence of bone growth along a superiorsurface 675 of implant 600. This new bone growth may occur prior to,simultaneously with, or after bone has grown through the interior ofimplant 600 as described above. While only the superior side is shown inFIGS. 17-20, it may be appreciated that similar bone growth patterns mayoccur on the inferior side of the implant simultaneously.

FIG. 17 depicts an isometric view of implant 600 inserted betweenvertebra 712 and vertebra 714 as well as an enlarged view of superiorsurface 675. It may be appreciated that, BGPM 700 is not visible in theenlarged view in FIG. 17. This is done for clarity so that new bonegrowth can be clearly seen as it forms along the surface of structuralmembers of implant 600.

In FIG. 18, new bone growth occurs in multiple locations on superiorsurface 675. Specifically, new bone growth region 802 occurs withincentral cavity 671, as described above and depicted in FIGS. 14-16. Inaddition, new bone growth regions 804 may first form at the protectedfusion zones discussed earlier. As disclosed in The Protected FusionZone Application, new bone growth regions 804 occurring in protectedfusion zones may be protected from local forces between bone contactingmembers and the vertebrae. This helps minimize the disturbance to newbone growth regions 804 in the protected fusion zones.

As shown in FIG. 19, eventually, new bone growth may extend from theprotective fusion zones to the entire length of plurality of bonecontacting members 630. In some embodiments, new bone growth maycontinue to grow along the surfaces of plurality of support members 632as well.

It may be appreciated that new bone growth similarly occurs on theinferior surface of implant 600, as well as extending around thelateral, posterior and anterior sides.

Finally, as seen in FIG. 20, new bone growth region 802 may cover theexterior, and fill the interior, of an implant. At this point, there maybe a new bone fusion portion 810 that extends between vertebra 712 andvertebra 714 that fuses the vertebrae together.

In some other embodiments, increased volume for bone graft material andeventually new bone growth may be created by removing one or morestructures that are disposed within an internal region of an implant.For example, in another embodiment, the structures connecting superiorand inferior rings (e.g., first support 226 and second support 228 shownin FIG. 3) could be removed. Still other modifications could be made toincorporate any of the structures and/or arrangements as disclosed inU.S. Pat. No. 10,213,317, issued on Feb. 26, 2019, and titled “Implantwith Supported Helical Members,” which is hereby incorporated byreference in its entirety.

Embodiments can include provisions for texturing one or more surfaces ofan implant. Such texturing can increase or otherwise promote bone growthand/or fusion to surfaces of the implant. In some embodiments, bonecontacting members may be textured while support members may not betextured. This helps initial bone growth to be directed along the bonecontacting members and especially into the protected fusion zones,rather than growing initially across support members. In otherembodiments, however, support members could include surface texturing.In still further embodiments, one or more surfaces of a body couldinclude surface texturing.

In some embodiments, the surface structure of one or more regions of animplant may be roughened or provided with irregularities. Generally,this roughened structure may be accomplished through the use of acidetching, bead or grit blasting, sputter coating with titanium, sinteringbeads of titanium or cobalt chrome onto the implant surface, as well asother methods. In some embodiments, the roughness can be created by 3Dprinting a raised pattern on the surface of one or more regions of animplant. In some embodiments, the resulting roughened surface may havepores of varying sizes. In some embodiments, pore sizes could rangebetween approximately 0.2 mm and 0.8 mm. In one embodiment, pore sizescould be approximately 0.5 mm. In other embodiments, surface roughnesscomprising pore sizes less than 0.2 mm and/or greater than 0.8 mm arepossible.

The embodiments can make use of the surface texturing parts, features,processes or methods as disclosed in The Protected Fusion ZoneApplication.

The implants for use in the spine have overall dimensions suitable forinsertion in the spine, typically between two vertebral bodies. Theshape of the implant and dimensions depends on the site into which it isinserted. Exemplary heights for implants such as implant 100 and implant600 include, but are not limited to, 5 mm to 30 mm. Other embodimentscould have incremental heights of any value in the range between theaforementioned range, most often between 8 mm and 16 mm. Still otherembodiments could have a height greater than 16 mm. Still otherembodiments could have a height less than 8 mm. Additionally, thehorizontal footprint of the implant could vary. Exemplary footprintsizes for any embodiments of the implant include, but are not limitedto, 15-20 mm in the anterior-posterior direction and 40-60 mm in thelateral-lateral direction. Still other embodiments could be configuredwith any other footprint sizes.

The dimensions of one or more structural members could vary. In someembodiments, a structural member could have a cross-sectional diameterin a range between 0.2 and 3 mm. For structural members with polygonalcross sections, the dimensions characterizing the polygon (e.g., firstand second diameters for an ellipse) could vary. As an example, astructural member with an elliptic cross section could have a crosssection with a first diameter in a range between 0.2 mm and 3 mm and asecond diameter in range between 0.2 mm and 3 mm. In other embodiments,a structural member could have any other cross-sectional diameter.Moreover, in some cases a bone contacting member and a support membercould have similar cross-sectional diameters while in other cases a bonecontacting member and a support member could have differentcross-sectional diameters.

Embodiments can also be provided with various flat/parallel (0-degree),lordotic, and hyper-lordotic angles. In some embodiments, the implantcan be configured with an approximately 8-degree angle between thesuperior and inferior surfaces. In other embodiments, the implant can beconfigured with an approximately 15-degree angle between the superiorand inferior surfaces. In still other embodiments, the implant can beconfigured with an approximately 20-degree angle between the superiorand inferior surfaces. Still other angles are possibly including anyangles in the range between 0 and 30 degrees. Still other embodimentscan provide a lordotic angle of less than 8 degrees. Still otherembodiments can provide a hyper-lordotic angle of more than 20 degrees.In at least some embodiments, the lordotic angle of the implant isaccomplished via the geometry of the central keel portion and the sideframe portion (posterior or anterior).

The various components of an implant may be fabricated frombiocompatible materials suitable for implantation in a human body,including but not limited to, metals (e.g. titanium or other metals),synthetic polymers, ceramics, and/or their combinations, depending onthe particular application and/or preference of a medical practitioner.

Generally, the implant can be formed from any suitable biocompatible,non-degradable material with sufficient strength. Typical materialsinclude, but are not limited to, titanium, biocompatible titanium alloys(e.g. γTitanium Aluminides, Ti₆—Al₄—V ELI (ASTM F 136 and F 3001), orTi₆—Al₄—V (ASTM F 2989, F 1108 and ASTM F 1472)) and inert,biocompatible polymers, such as polyether ether ketone (PEEK) (e.g.PEEK-OPTIMA®, Invibio Inc and Zeniva Solvay Inc.). Optionally, theimplant contains a radiopaque marker to facilitate visualization duringimaging.

In different embodiments, processes for making an implant can vary. Insome embodiments, the entire implant may be manufactured and assembledvia readditional/CNC machining, injection-molding, casting,insert-molding, co-extrusion, pultrusion, transfer molding, overmolding,compression molding, 3-Dimensional (3-D) printing (including DirectMetal Laser Sintering and Electron Beam Melting), dip-coating,spray-coating, powder-coating, porous-coating, milling from a solidstock material and their combinations. Moreover, the embodiments canmake use of any of the features, parts, assemblies, processes and/ormethods disclosed in the “The Coiled Implant Application”.

While various embodiments have been described, the description isintended to be exemplary, rather than limiting, and it will be apparentto those of ordinary skill in the art that many more embodiments andimplementations are possible that are within the scope of theembodiments. Although many possible combinations of features are shownin the accompanying figures and discussed in this detailed description,many other combinations of the disclosed features are possible. Anyfeature of any embodiment may be used in combination with or substitutedfor any other feature or element in any other embodiment unlessspecifically restricted. Therefore, it will be understood that any ofthe features shown and/or discussed in the present disclosure may beimplemented together in any suitable combination. Accordingly, theembodiments are not to be restricted except in light of the attachedclaims and their equivalents. Also, various modifications and changesmay be made within the scope of the attached claims.

1-20. (canceled)
 21. An implant, comprising: a body including a ring,the ring further defining an opening; the body defining a transverseplane dividing the implant into a superior half and an inferior half;the ring defining a radial direction and a circumferential direction; aouter member attached to the ring, wherein the outer member extendsradially from the ring; wherein the outer member has a generally helicalgeometry; and wherein the ring further defines a central channelextending through the implant.
 22. The implant according to claim 21,wherein the central channel extends from a superior side to an inferiorside of the implant.
 23. The implant according to claim 21, wherein thering is located in a central region of the implant.
 24. The implantaccording to claim 21, wherein the body includes a peripheral frameportion that defines an outer periphery of the implant; and wherein theouter member extends from the ring to the peripheral frame portion. 25.The implant according to claim 21, wherein the outer member is a firstouter member, and wherein the implant further includes a second outermember having a generally helical geometry.
 26. The implant according toclaim 25 wherein the implant further includes a third outer member and afourth outer member.
 27. The implant according to claim 26, wherein thefirst outer member and the second outer member extend from a first sideof the ring to a first end of the implant, and wherein the third outermember and the fourth outer member extend from a second side of the ringto a second end of the implant.
 28. The implant according to claim 27,wherein the implant further includes a plurality of supports, whereineach of the plurality of supports are attached to at least one outermember, and wherein each of the plurality of supports extend in thecircumferential direction.
 29. The implant according to claim 28,wherein the first outer member, the second outer member, the third outermember, the fourth outer member and the plurality of supports arearranged in a web-like pattern.
 30. The implant according to claim 29,wherein the web-like pattern is disposed in the superior half of theimplant, and wherein the implant has another web-like pattern formed ofouter members and supports disposed in the inferior half of the implant.31. The implant according to claim 21, further including a supportattached to the outer member at an attachment region, wherein thesupport extends in the circumferential direction.
 32. The implantaccording to claim 31, wherein at the attachment region the support isdisposed closer to the transverse plane than the outer member is to thetransverse plane.
 33. An implant, comprising: a body; the body defininga transverse plane dividing the implant into a superior half and aninferior half; a first outer member attached to the body and disposedwithin the superior half of the implant; a first support attached to thefirst outer member, the first support being disposed within the superiorhalf of the implant; a second outer member attached to the body anddisposed within the inferior half of the implant; a second supportattached to the second outer member, the second support being disposedwithin the inferior half of the implant; wherein an end of the firstsupport is attached to an end of the second support; and wherein thefirst outer member and the second outer member each have a generallyhelical geometry; wherein the implant includes a first ring disposed inthe superior half, wherein the first outer member is attached to thefirst ring; the implant includes a second ring disposed in the inferiorhalf, wherein the second outer member is attached to the second ring;wherein the first ring and the second ring define a central channelextending through the implant.
 34. The implant according to claim 33,wherein the first ring is joined to the second ring by additionalsupports extending through the transverse plane, such that the firstring and the second ring define openings for the central channelextending through the implant.
 35. The implant according to claim 33,wherein the central channel extends from a superior side to an inferiorside of the implant.
 36. The implant according to claim 33, wherein thefirst ring and the second ring are located in a central region of theimplant.
 37. An implant, comprising: a body; the body defining atransverse plane dividing the implant into a superior half and aninferior half; a plurality of outer members disposed within the superiorhalf of the implant and extending from a central region of the body to aperiphery of the body; and wherein each of the outer members in theplurality of outer members extend radially away from the central regionof the body; wherein each of the plurality of outer members have ageneralized helical geometry; and wherein the implant includes at leastone ring disposed in the central region of the body and defining acentral channel extending through the implant from a superior side to aninferior side of the body.
 38. The implant according to claim 37,wherein the implant includes three or more outer members.
 39. Theimplant according to claim 37, wherein the body includes a peripheralframe portion that defines an outer periphery of the implant; andwherein the outer members extend from the ring to the peripheral frameportion.
 40. The implant according to claim 37, wherein the implantfurther includes a plurality of supports, wherein each of the pluralityof supports are attached to at least one outer member, and wherein eachof the plurality of supports extend in a circumferential directiondefined by the at least one ring.